Rilpivirine Versus Efavirenz in HIV-1–Infected Subjects Receiving Emtricitabine/Tenofovir DF: Pooled 96-Week Data from ECHO and THRIVE Studies

Abstract

The pooled ECHO and THRIVE studies demonstrated noninferiority of RPV+FTC/TDF in achieving virologic response with safety and tolerability advantages over EFV+FTC/TDF through 96 weeks. Higher rates of virologic failure in the RPV+FTC/TDF group were balanced with higher rates of discontinuations due to adverse events in the EFV+FTC/TDF group.

Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate Single-Tablet Regimen: A Review of Its Use in HIV Infection

“…Notably, the change in the TC: HDL-C ratio at these timepoints was the same in each group (-0.2) [22,23]. These findings are generally supported by pooled 96-week data from the ECHO and THRIVE trials in ART-naïve patients who received either rilpivirine or efavirenz in combination with emtricitabine/tenofovir DF; lipid-lowering therapies were used by significantly (p = 0.025) fewer patients in the rilpivirine than in the efavirenz group (3 vs. 6 %) [15].…”

“…4) [10]. Up to fivefold more rilpivirine plus emtricitabine/tenofovir DF than efavirenz plus emtricitabine/tenofovir DF recipients developed NNRTI RAMs (7.1 vs. 2.7 %) or NRTI RAMs (7.5 vs. 1.5 %) through 96 weeks of therapy in the overall patient population (n = 550 and 546) [15]. However, during this period, few patients (\4 %) whose viral load was B100,000 copies/mL at baseline developed phenotypic resistance to study drug [16] or genotypic resistance to NRTIs or NNRTIs [17] in either regimen group.…”

Emtricitabine/rilpivirine/tenofovir disoproxil fumarate single-tablet regimen in HIV-1 infection: a guide to its use in the EU

“…cell count did not significantly differ between the two regimens at either timepoint [11,12], and although the rate of virological failure was 1.4-and 1.6-fold higher with the rilpivirine-than with the efavirenzbased regimen at 48 [11] and 96 weeks [12], the betweengroup difference was reported as not significant at week 48 [11] (Table 2). These findings are generally supported by a pooled subset analysis of two earlier trials (ECHO and THRIVE) in patients who received rilpivirine or efavirenz in combination with emtricitabine/tenofovir DF (Table 2) [8,13,14].…”

“…In treatment-naïve adults, combination therapy with emtricitabine, rilpivirine and tenofovir DF appeared to have a more favourable overall tolerability profile than combined use of emtricitabine, efavirenz and tenofovir DF, according to STaR [12] and a pooled analysis [13] of ECHO and THRIVE. For instance, over 96 weeks of therapy in STaR, treatment was discontinued because of adverse events in 3.6-fold more recipients of the emtricitabine/efavirenz/tenofovir DF than emtricitabine/rilpivirine/tenofovir DF single-tablet regimen, with psychiatric disorders (6 %) and neurological disorders (0.8 %) being the events most commonly causing discontinuation in the respective groups [12].…”

“…Consistent with STaR, all patients in a smaller trial (Study 111; n = 49) who were already virologically suppressed with the emtricitabine/efavirenz/tenofovir DF single-tablet regimen, but wished to change their regimen because of efavirenz intolerance, sustained a viral load of \50 copies/mL 12 weeks after switching to the emtricitabine/rilpivirine/tenofovir DF single-tablet regimen [8,13] or full analysis set [11,12], using the time-to-loss-of-virological response [8,13] or snapshot [11,12] algorithm for virological outcomes BL baseline, EFV efavirenz, FTC emtricitabine, pts patients, RPV rilpivirine, TDF tenofovir disoproxil fumarate a Pts received FTC/RPV/TDF 200 mg/25 mg/300 mg or FTC/EFV/TDF 200 mg/600 mg/300 mg as once-daily single-tablet regimens in STaR, and RPV 25 mg or EFV 600 mg once daily in combination with FTC/TDF in ECHO and THRIVE b Primary endpoint at week 48 c 95 % confidence interval for the difference between the RPV group and comparator group d RPV regimen was noninferior to the EFV regimen, based on a noninferiority margin of 12 % for the between-regimen difference e Statistical analysis for between-group difference was not reported (primary endpoint), with most patients continuing to sustain this degree of suppression up to 48 weeks (Table 3) [30,31]. At 48 weeks, no significant change in CD4?…”